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Corneal and Conjunctival Sensitivity and Staining Study
This study is currently recruiting participants.
Verified by University of Waterloo, March 2007
Sponsors and Collaborators: University of Waterloo
Alcon Research
Information provided by: University of Waterloo
ClinicalTrials.gov Identifier: NCT00455455
  Purpose

The primary objective of this study is to compare subjective symptoms and ocular health in a group of individuals who are currently wearing soft contact lenses on a daily wear basis, after a short period of no lens wear and during the time course when using differing care regimens.


Condition Intervention Phase
Myopia
Hyperopia
Drug: Optifree RepleniSH Multipurpose Disinfecting Solution
Drug: ReNu Multiplus Multipurpose Solution
Phase IV

U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Active Control, Crossover Assignment, Safety/Efficacy Study
Official Title: Corneal and Conjunctival Sensitivity and Staining Study

Further study details as provided by University of Waterloo:

Primary Outcome Measures:
  • Corneal sensitivity
  • conjunctival sensitivity
  • corneal staining
  • conjunctival staining

Secondary Outcome Measures:
  • ocular redness

Estimated Enrollment: 50
Study Start Date: March 2007
Estimated Study Completion Date: December 2007
  Eligibility

Ages Eligible for Study:   17 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

An eligible participant is one who:

  • Is between 17-45 years old and has full legal capacity to volunteer.
  • Has read and signed an information consent letter, after having the opportunity to ask questions and receive acceptable answers.
  • Is willing and able to follow instructions and maintain the appointment schedule.
  • Does not experience any dryness related symptoms during lens wear (i.e. at least 12 hours of comfortable wearing time)
  • Is correctable to a visual acuity of 6/7.5 (20/25) or better (each eye) with their habitual vision correction.
  • Has normal binocular vision (no strabismus, no amblyopia).
  • Has clear corneas and no active ocular disease.
  • Has had an ocular examination in the last two years. Has a distance contact lens prescription between +0.50D to +6.00 DS and –0.50D and –12.00 DS.
  • Has astigmatism less than or equal to –1.00DC.
  • Agrees to wear the study lenses on a daily wear basis.
  • Has a pair of glasses with updated prescription and agrees to wear them during the period no lens wear (7-10 days) as required by the study.

Exclusion Criteria:

A person is ineligible if he/she:

  • Has undergone corneal refractive surgery.
  • Is aphakic.
  • Has any active ocular disease.
  • Has any systemic disease affecting ocular health.
  • Is using any systemic or topical medications that may affect ocular health.
  • Has a known sensitivity to the diagnostic pharmaceuticals to be used in the study.
  • Is pregnant or lactating.
  • Is participating in any other clinical or research study.
  • Has a known clinically significant sensitivity to the contact lens care solutions used in the study.
  • Has ocular or systemic allergies that could adversely affect contact lens wear.
  • Currently wears lenses on a continuous or extended wear basis.
  • Has any ocular pathology or severe insufficiency of lacrimal secretion (dry eyes) that would affect the wearing of contact lenses.
  • Has pinguecula/pterygium that, in the investigator’s judgment, makes contact lens wear inadvisable.
  • Is a rigid lens wearer.
  • Has corneal staining graded as 2 (macropunctate) or greater in any corneal region in either eye, sum of corneal staining type (severity) of greater than or equal to 4 across the entire cornea in either eye, or any corneal staining covering greater than or equal to 20% in any corneal region in either eye.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00455455

Contacts
Contact: Craig A Woods, Ph.D. 1 519 888 4567 ext 36547 cawoods@uwaterloo.ca

Locations
Canada, Ontario
Centre for Contact Lens Research, School of Optometry Recruiting
Waterloo, Ontario, Canada, N2L 3G1
Contact: Craig A. Woods, Ph.D.     519-888-4567 ext 36547     cawoods@sciborg.uwaterloo.ca    
Sponsors and Collaborators
University of Waterloo
Alcon Research
Investigators
Principal Investigator: Desmond Fonn, M.Optom University of Waterloo
  More Information

Study ID Numbers: P/245/06/L
Study First Received: March 23, 2007
Last Updated: April 2, 2007
ClinicalTrials.gov Identifier: NCT00455455  
Health Authority: Canada: Health Canada

Study placed in the following topic categories:
Hyperopia
Eye Diseases
Myopia
Refractive Errors

ClinicalTrials.gov processed this record on January 16, 2009